magnesium sulfate

Orange BookUNIISPLATC D11AX05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeD11AX05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6332310601
24 BAG in 1 CASE (63323-106-01) / 100 mL in 1 BAG (63323-106-00)
ndc11
6332310605
24 BAG in 1 CASE (63323-106-05) / 50 mL in 1 BAG (63323-106-02)
ndc11
6332310610
24 BAG in 1 CASE (63323-106-10) / 1000 mL in 1 BAG
ndc11
6332310615
24 BAG in 1 CASE (63323-106-15) / 500 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

SK47B8698T

MAGNESIUM SULFATE HEPTAHYDRATE

RxCUI 236741

Orange Book

A206485

APAPAPAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "SK47B8698T",
    "rxcui": "236741",
    "inchikey": "WRUGWIBCXHJTDG-UHFFFAOYSA-L",
    "display_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "9875ae6b-2d91-49a3-9512-60a2b8bbccda": {
      "match": "brand_token",
      "title": "MAGNESIUM OXIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-05-25"
    }
  },
  "productid": "63323-106_48486022-130e-4a6a-87e7-db7c53eb5e75",
  "productndc": "63323-106",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206485",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4GM/100ML (40MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4GM/50ML (80MG/ML)",
        "product_no": "002",
        "approval_date": "Mar 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/50ML (40MG/ML)",
        "product_no": "003",
        "approval_date": "Mar 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20GM/500ML (40MG/ML)",
        "product_no": "004",
        "approval_date": "Mar 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40GM/1000ML (40MG/ML)",
        "product_no": "005",
        "approval_date": "Mar 15, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
  "proprietary_name": "magnesium sulfate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA206485",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MAGNESIUM SULFATE HEPTAHYDRATE",
  "start_marketing_date": "20160315",
  "active_numerator_strength": "40"
}

Related drugs

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